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A clinical trial, or research study, is the scientific term for a test or study of a drug, therapy, surgical procedure, medical device, or of nutrition or behavioral changes in people.
The tests are conducted to determine if the drug, therapy, procedure, etc., is safe and effective for people to use. The overall purpose of a study is to learn, not to treat patients. Before you volunteer to participate in a study, ask about any risks associated with the treatment being tested.
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An individual who participates in a clinical trial, either as recipient of an investigational product or as a control. Subjects may include both healthy individuals and patients.
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Informed consent is a critical ethical process and requirement in clinical trials, ensuring that participants or their legally authorized representatives are fully informed about the study’s details before agreeing to participate.
This process involves clearly explaining the purpose, procedures, risks, benefits and rights related to the trial. Participants must receive all the information necessary to make an educated decision about their involvement, ensuring their consent is given freely and without coercion.
For minors and individuals unable to provide consent on their own, informed consent must be obtained from their legally designated representatives. The goal of informed consent is to protect participants and uphold their autonomy by providing them with sufficient information to make an informed choice about their participation in the research.
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By taking part in research studies, you can try a potential new treatment that may (or may not) be better than standard treatments available. Your participation may also help people who may be suffering from the same disease or condition in the future. Please visit this link to view our ongoing clinical trials
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The clinical trials take place in the resolute CTU clinic within SSMC hospital facilities.
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Placebos are inactive substances that resemble the active substances studied in clinical studies. The purpose of this study is to determine if there is a placebo effect within this group, i.e., if patients treated with a placebo experience any positive effects.
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During clinical trials, randomization is used to ensure that an equal proportion of patients receive every specific treatment by chance and that these groups share the same measured and unmeasured characteristics. Throughout the trial, the results of each treatment are compared at intervals, and as soon as one treatment is found to be more effective than the other, the trial is stopped.
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Blinding plays an important role in ensuring the validity of a randomized controlled trial. A double-blinded experiment is one in which neither the participants nor the experimenters are aware of which treatment each participant is receiving.
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Most costs in a clinical trial are covered by grants or funds contributed by the trial sponsor. Routine procedures — such as blood tests or other lab work that you would need whether or not you were participating in a trial — are usually covered by your insurance.
Each trial is different, so it’s best to check with the study coordinator to find out about costs. -
Yes, participants may leave any clinical trial at any time without affecting their access to care at SSMC.
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Please visit this link for participant application information.
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For inquiries regarding clinical trials at SSMC, please contact [email protected]. This includes queries on whether you are eligible to enroll in clinical trials at SSMC.